Description of the Copper Concentration in Breast Milk in Women Treated for Wilson's Disease
NCT ID: NCT05183165
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-05-11
2026-08-31
Brief Summary
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The consensus is to maintain treatment during pregnancy, reducing the dosage to limit teratogenicity as well as the risk of fetal copper deficiency.The mammary gland is the primary site of copper metabolism in lactation, and ATPase 7B is the primary effector.
It has been shown in a mouse model of Wilson's disease (ATP7B - / - mouse) with treatment, that mothers accumulate copper in the liver but also in the mammary gland.
However, a recent study showed that the copper level in breast milk was normal in 18 Wilsonian patients treated with D-penicillamine, trientine salts or zinc salts, suggesting that breastfeeding is possible in these patients without risk to the development of the infants.The problem of breastfeeding newborns for patients with Wilson's disease is therefore associated with a risk of copper deficiency in the newborn due to insufficiently rich breast milk in copper due to drugs.
In addition, the passage into breast milk of treatments is not sufficiently known.
These factors make breastfeeding not currently recommended for Wilsonian mothers,However, many patients wish to breastfeed and some of them breastfeed their newborns despite the risk of breastfeeding
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients with Wilson's disease declaring pregnancy,
Patients with Wilson's disease declaring pregnancy.Followed in the reference, constituent, and competence centers for Wilson's disease and other rare copper-related diseases, spread over French national territory.
Patients with Wilson's disease declaring pregnancy,
Blood and urine biological assessment Dietary assessment
Interventions
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Patients with Wilson's disease declaring pregnancy,
Blood and urine biological assessment Dietary assessment
Eligibility Criteria
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Inclusion Criteria
* Wilson's disease fulfilling the criteria for the Leipzig score
* Pregnancy in progress whatever the term.
* Express consent to participate in the study.
* Affiliate or beneficiary of a social security system.
Criteria for non-inclusion :
* Liver transplant patient
* No affiliation to Social Security system
* VuInability to give free and informed consent
* Patient benefiting from a legal protection measure
18 Years
FEMALE
No
Sponsors
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Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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Locations
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Fondation Adolphe de Rothschild
Paris, , France
Countries
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Central Contacts
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Mickael Alexandre OBADIA
Role: CONTACT
Facility Contacts
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Other Identifiers
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AOA_2021_28
Identifier Type: -
Identifier Source: org_study_id